SDF1 Plasmid Treatment for Patients With Peripheral Artery Disease
STOP-PAD
A Phase 2B Randomized Double Blind Placebo Controlled Study to Evaluate the Safety and Efficacy of JVS-100 Administered by Direct Intramuscular Injection as Adjunct to Revascularization of Infrapopliteal Lesions in Subjects With Advanced Peripheral Artery Disease and Tissue Loss
1 other identifier
interventional
120
1 country
24
Brief Summary
To investigate the efficacy of the administration of JVS-100 delivered via direct intramuscular injections on a 3 month and 6 month composite endpoint of wound progression, healing and limb loss in patients with severe peripheral arterial disease with non-healing chronic wounds who undergo an open bypass grafting or endovascular procedure for treatment of infrapopliteal disease and are dosed within 12 days and 3 months following the procedure.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Nov 2015
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
September 9, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2017
CompletedNovember 2, 2016
November 1, 2016
1.8 years
August 6, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
Change from baseline in the composite endpoint at 3 months in all treated (or one JVS-100 dose group) compared to all placebo.
3 months
The composite is designed to quantify clinically significant improvement or worsening over baseline by assigning a score to each patient that represents their overall outcome.
Change from baseline in the composite endpoint at 6 months in all treated (or one JVS-100 dose group) compared to all placebo.
6 months
Study Arms (4)
8 mg JVS-100
ACTIVE COMPARATORBiological/Vaccine: JVS-100 Injection Intramuscular Injection
8 mg placebo
PLACEBO COMPARATORBiological/Vaccine: Placebo Injection Intramuscular Injection
16 mg JVS-100
ACTIVE COMPARATORBiological/Vaccine: JVS-100 Injection Intramuscular Injection
16 mg placebo
PLACEBO COMPARATORBiological/Vaccine: Placebo Injection Intramuscular Injection
Interventions
Eligibility Criteria
You may qualify if:
- Age ≥18
- Currently receiving standard of care wound treatment (\>2 weeks) for chronic wounds or gangrene including as indicated: debridement, pressure offloading, infection control, and/or maintenance of a moist wound environment.
- Diagnosis of advanced PAD with tissue loss (ulceration and/or dry gangrene) on the foot of the index leg with an ulcer size of at least 0.5 cm2 and \<25 cm2. Index wounds on the heel must be \<10 cm2 that cannot be probed to bone, have exposed bone or osteomyelitis.
- TBI ≤ 0.51or;
- Toe pressure ≤50 mmHg with flat or dampened wave forms or;
- Skin Perfusion pressure ≤40 mmHg at mid foot level or;
- TcPO2 ≤40 mmHg
- Subjects willing to forgo treatment with hyperbaric oxygen, nerve stimulation or sympathectomy for the treatment of advanced PAD from time of consent to 6 months following the initial injection of study drug
You may not qualify if:
- Previous major amputation of the leg to be treated or planned major amputation or transmetatarsal amputation within the first month following enrollment.
- Only a short segment superficial femoral artery lesion - consistent with Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A or B category, and no infrapopliteal disease
- Staged or planned intervention in the index leg within 30 days after the index procedure
- Acute limb-threatening ischemia, trauma, known non-atherosclerotic vascular disease
- Non-salvageable limb defined as major tissue loss and an unsalvageable foot;
- Wounds that have decreased in size by \>50% between the Screening visit and Day 0.
- If patient has active infection of the index limb that is being treated, and, in the opinion of treating physician, will not lead to an amputation within the next 3 months, the patient can be enrolled.
- Inability to safely perform a revascularization procedure due to uncontrolled diabetes or other medical condition.
- Presence of any other condition that, in the opinion of the investigator, might compromise any aspect of the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Cardiovascular Associates of the Southeast
Birmingham, Alabama, United States
UC Davis
Davis, California, United States
Cedars-Sinai Heart Institute
Los Angeles, California, United States
MedStar Georgetown UH
Washington D.C., District of Columbia, United States
Morton Plant Hosptial - Baycare
Clearwater, Florida, United States
Mount Sinai Medical Center
Miami, Florida, United States
St. Joseph's Hospital
Tampa, Florida, 33614, United States
Northwestern
Chicago, Illinois, United States
RUMC
Chicago, Illinois, United States
Cardiovascular Institute of the South
Houma, Louisiana, United States
St. John Hospital and Medical Center
Detroit, Michigan, United States
Mayo
Rochester, Minnesota, United States
Cardiology Associates Research
Tupelo, Mississippi, United States
St. Luke's Mid America Heart Institute
Kansas City, Missouri, United States
Holy Name Medical Center
Teaneck, New Jersey, United States
UNC
Chapel Hill, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
Summa Health
Akron, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Metro Health
Cleveland, Ohio, United States
University Hospitals
Cleveland, Ohio, United States
Lifespan Health System
Providence, Rhode Island, United States
VCU
Richmond, Virginia, United States
Medical College of Wisconsin
Milwauke, Wisconsin, United States
Related Publications (2)
Hammad TA, Rundback J, Bunte M, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD, Shishehbor MH. Stromal Cell-Derived Factor-1 Plasmid Treatment for Patients With Peripheral Artery Disease (STOP-PAD) Trial: Six-Month Results. J Endovasc Ther. 2020 Aug;27(4):669-675. doi: 10.1177/1526602820919951. Epub 2020 May 18.
PMID: 32419594DERIVEDShishehbor MH, Rundback J, Bunte M, Hammad TA, Miller L, Patel PD, Sadanandan S, Fitzgerald M, Pastore J, Kashyap V, Henry TD. SDF-1 plasmid treatment for patients with peripheral artery disease (STOP-PAD): Randomized, double-blind, placebo-controlled clinical trial. Vasc Med. 2019 Jun;24(3):200-207. doi: 10.1177/1358863X18817610. Epub 2019 Feb 21.
PMID: 30786835DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 6, 2015
First Posted
September 9, 2015
Study Start
November 1, 2015
Primary Completion
September 1, 2017
Study Completion
November 1, 2017
Last Updated
November 2, 2016
Record last verified: 2016-11